FDA RELEASES DOCUMENTS PRIOR TO YAZ SIDE EFFECT ADVISORY HEARINGS

FDA has released, and posted, briefing documents relating to the 12.8.11 joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. These documents provide a some insight into the anticipated dialogue and discourse the hearings are expected to generate. The FDA released the documents on 12.6.11 and they are available at http://www.fda.gov/

The Washington Post reports that “FDA Say YAZ and Relate Birth Control Pills Should Carry More Info About Risk of Blood Clots” and cites the briefing documents. In sum, they quote an excerpt from the FDA’s background documents which concludes “[w]e believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility“. FDA’s review is also noted as concluding that conflicting studies cannot be easily reconciled.

MedPage Today, Washington Correspondent, Emily P. Walker, notes in “BAYER Charged with Burying Negative VTE Data for Yasmin” that former FDA Commissioner, David Kessler, M.D., has been hired as an expert witness for women with lawsuits pending against the manufacturer, BAYER. MedPage qoutes Kessler as stating:

  • By failing to disclose all thromboembolic event risk information and marketing YAZ and YASMIN off-label, BAYER needlessly explosed large numbers of women to risks of serious or fatal thromboembolic events“.
  • In my opinion, BAYER had a duty to present a full and balanced view of all the data and analysis concerning YASMIN to the FDA and healthcare professionals and failed to do so“.
  • It appears, based on the information that I have reviewed, and it is my opinion, that BAYER presented a selective view of the data, and that presentation obscured the potential risks associated with YASMIN“.
  • BAYER engaged in extensive, systematic off-label promotion of YASMIN and YAZ for PMS, in violation of FDA law and regulations, thereby unnecessarily exposing large numbers of women to risk of thrombembolic events in violation of state law duties“.

Kessler’s opinions and statements illustrate the need for public scrutiny, as well as continued, and vigilant, regulatory intervention of DRSP (DROSPIRENONE) containing birth control. (Visit “YAZ DRSP & FDA HISTORY 2000-2011″ on this site for a chronological history of the pills and FDA action)

In the face of new science, FDA hearings and emerging scientific evidence, BAYER continues to rely upon prior studies to defend the safety and effectiveness of the DRSP (DROSPIRENONE) family of birth control. Despite mutiple studies, since 2009, as well as FDA’s own study that concluded the pills present a higher blood clot risk than other available hormonal contraceptives, BAYER continues to claim the new studies are flawed or unreliable, thus giving rise for current scientific debate and evaluation.

Regardless of the statistical likelihood of a girl or woman experiencing a blood clot noone should look past the statements of former FDA Commissioner Kessler and his evaluation of confidential and proprietary documents. Girls and women that have taken any DRSP (DROSPIRENONE) pill, YASMIN, YAZ, BEYAZ, SAFYRAL and their generics, have to consider whether or not they were adequately informed at the time of potential risks. The pills have now been available for nearly a decade and the warning labels have only been updated to reflect increased warnings in the past 18 months. FDA hearings may only result in yet another modification to the warning. What does that do for the Generation of Women that took the pills and suffered injuries over the past decade? What does that do for women, or girls, that were injured and did not find lawyers prior to 2009 when studies began to emerge calling the manufacturer’s labeling into question? What does it do for those who have sought legal representation and been told the “Statute of Limitations“, “Statute of Repose” or legal time frame within which to seek a legal remedy has expired?

Kessler’s statements substantiate that they were knowingly exposed to risks, regardless of whether the suffered any harm. Similarly, medical providers have to also question the information that was disclosed to them to aid in making informed decisions with patients. Based upon the legacy DRSP (DROSPIRENONE) pills have already left in the past decade, what future, if any the pills have after 12.8.11 remains to be seen. We will report and monitor on any developments following the hearings. You may contact the sponsor of this site with any questions, or if you have suffered injuries from DRSP (DROSPIRENONE) for a FREE CASE EVALUATION. The sponsor of this site is:

Gabriel F. Zambrano
Gabriel F. Zambrano, P.A.
1900 N.W. Corporate Boulevard
Suite 450 – West
Boca Raton, FL  33431

 

 

 

YAZ DRSP (DROSPIRENONE) GENERICS

On November 29, 2011, FDA reportedly approved an application for a generic of BAYER’s trademarked YAZ by WATSON PHARMACEUTICALS. Related news reports , and PR releases indicate that WATSON is embroiled in a patent dispute with BAYER over the product. The new generic to enter into the DRSP (DROSPIRENONE) family is to be called VESTURA.

FDA has scheduled hearings during December 2011 of expert panels to discuss the already confirmed and significantly higher risk of blood clots DRSP (DROSPIRENONE) containing birth control pills present to users. Civil jury trials over the pills are set for January 2012. As a result, these pills will remain in the news and public spotlight as some FDA action is anticipated regardless of this recent FDA approval.

The generic market is a potential money maker for pharmaceutical companies as trademarked pills approach the “patent cliff” where a pill loses initial patent protection and open competition can begin on pricing and manufacture.

Notably, there are already a number of DRSP (DROSPIRENONE) generics approved by FDA.

The YASMIN generics, or related pills, include the following:

  • Ocella
  • SAFYRAL
  • Syeda
  • Zarah
The YAZ generics, or related pills, include the following:
  • BEYAZ
  • Gianvi
  • Loryna
  • Vestura

What impact, if any, FDA’s December 2011 hearings will have on DRSP (DROSPIRENONE) labeling, warning or packaging remains open to some debate. We will provide updates as they become available or are publicly reported.

Generic Ocella

OCELLA is DRSP generic.

Sadly, the Vermont Journalism Trust, through VTDIGGER.ORG is reporting that 21 year old, April Bapp, died on 11.12.11 from use of DRSP (DROSPIRENONE) generic – OCELLA. The original story, and obituary, were originally published in the BARTON CHRONICLE, and re-published in VTDIGGER.ORG’s, “YOUNG WOMAN’S DEATH LEADS TO QUESTIONS ABOUT POPULAR CONTRACEPTIVE KNOWN AS YAZ“. The original reporter, Tena Starr, explained how Bapp suffered from difficulty breathing and was transported by her parents to a hospital prior to passing away. An autopsy revealed that she died from a blood clot in her heart with secondary cause of death being identified as oral contraceptive. Notably, she was taking the YASMIN generic OCELLA which was at one point actually manufactured along with other DRSP (DROSPIRENONE) containing contraceptives in Germany by BAYER pursuant to a licensing agreement. OCELLA was recalled, as noted in FDA ENFORCEMENT REPORTS on 11.25.09, along with YAZ boxes for failure to meet current good manufacturing practices.

Only yesterday (as noted above), a new YAZ generic – VESTURA – was approved for manufacture by WATSON PHARMACEUTICALS. Safety and effectiveness of DRSP (DROSPIRENONE) pills, and their increased risk of blood clots, will be the subject of FDA hearings on 12.8.11. Will FDA experts recommend stronger warnings, yet another – which will be the 3rd label change to warnings – or can the status quo continue despite FDA funded studies confirming significantly increased risk of blood clots? On the heels of another generic approval, and the reports of April Bapp’s death, all interested parties will be under public scrutiny as a Generation of Girls & Women have already been subjected to a decade of risk with “evolving warnings” that have resulted in over 10,000 lawsuits. We will update this site as more information relating to these pills, their future, and FDA’s action plan becomes available.